In 2013 the US Food and Drug Administration (FDA) ordered 23andMe to discontinue marketing its personal genome service (PGS), as the company had not obtained the legally required regulatory approval. That resulted in concerns about the potential consequences of customers receiving inaccurate health results.[3] The company continued to sell a personal genome test without health-related results in the United States until October 21, 2015, when it announced that it would be including a revised health component with FDA approval.[4][5] 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014,[6][7][8] and in the United Kingdom since December 2014.[9]

In 2012, 23andMe raised $50 million in a Series D venture round, almost doubling its existing capital of $52.6 million.[15][16][17] In 2015, 23andMe raised $115 million in a Series E offering, increasing its total capital to $241 million.[5][18][19]

23andMe began offering direct to consumer genetic testing in November 2007. Customers provide a saliva testing sample that is partially SNP genotyped and results are posted online.[10][21][22] In 2008, when the company was offering estimates of "predisposition for more than 90 traits and conditions ranging from baldness to blindness", Time magazine named the product Invention of the Year.[2]

Uninterpreted raw genetic data is posted online and may be downloaded by customers.[23] Customers who bought tests with an ancestry-related component have online access to genealogical DNA test results and tools including a relative-matching database. US customers who bought tests with a health-related component and received health-related results before November 22, 2013 have online access to an assessment of inheritedtraits and genetic disorder risks.[4][24][25] Health-related results for US customers who purchased the test from November 22, 2013 were suspended until late 2015 while undergoing an FDA regulatory review.[5][26][27] Customers who bought tests from 23andMe's Canadian and UK locations have access to some health-related results.[6][9]

As of June 2015, 23andMe has genotyped over 1,000,000 individuals.[28][29] FDA marketing restrictions have reduced customer growth.[30]

In late 2009, 23andMe split its genotyping service into three products with different prices, an Ancestry Edition, a Health edition, and a Complete Edition.[31] This decision was reversed a year later when the different products were recombined.[32] In late 2010 the company introduced a monthly subscription fee for updates based on new medical research findings.[32][33] The subscription model proved unpopular with customers and was eliminated in mid-2012.[34]

23andMe sold only raw genetic data and ancestry-related results in the United States due to FDA restrictions from November 22, 2013 until October 21, 2015,[4][26][27] when it announced that it would resume providing health information in the form of carrier status and wellness reports with FDA approval.[35] Wojcicki said they still plan to report on disease risk, subject to future FDA approval.[5]

The price of the full direct-to-consumer testing service in the United States reduced from $999 in 2007 to $99 in 2012,[15] and was effectively being sold as a loss leader in order to build a valuable customer database.[23][36][37] In October 2015, the US price was raised to $199.[35] In September 2016, an ancestry-only version was once again offered at a lower price of $99 with an option to upgrade to include the health component for an additional $125 later.[38] The price for international customers was lowered from $199 to $149. To date this kit offers only ancestry information[39]

The initial price of the product sold in Canada from October 2014, which includes health-related results, was C$199.[6][7] The initial price of the product sold in the UK from December 2014, which includes health-related results, was £125.[40]

Aggregated customer data is studied by scientific researchers employed by 23andMe for research on inherited disorders. The large pool of data in its customer database has also attracted the interest of academics and other partners,[30] including pharmaceutical and biotechnology companies.[23][42] In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions.[43]

23andMe provides services related to some specific medical research initiatives,[44] providing confidential customer datasets to and partnering with researchers to establish genetic associations with specific illnesses and disorders.[10] One analysis comparing 23andMe's Parkinson's disease research with a National Institutes of Health initiative suggested that the company's use of large amounts of computational power and datasets might offer comparable results, in much less time.[45] 23andMe has launched research initiatives enrolling patients into study populations for inflammatory bowel disease, myeloproliferative neoplasms, and lupus.[46][47] Papers on various genetic traits by 23andMe scientists were presented at the 2014 American Society of Human Genetics.[48]

In 2015, 23andMe made a business decision to pursue drug development themselves, under the direction of former Genentech executive Richard Scheller, as opposed to supplying pharmaceutical companies with raw data.[5][49]

The new genetic testing service and ability to map significant portions of the genome has raised controversial questions, including whether the results can be interpreted meaningfully and whether they will lead to genetic discrimination.[2][23] The regulatory environment for testing companies has been uncertain, and anticipated risk-based regulation catering for different types of genetic tests has not yet materialized.[32][50][51]

In 2008 it was reported that the states of New York and California unsuccessfully attempted to block such tests, provided by 23andMe as well as other companies, on the grounds that they were not properly licensed, and attempted to require tests to be conducted only when ordered by a physician.[2][52][53] By August 2008, 23andMe had received licenses that allow them to continue to do business in California.[54]

According to Anne Wojcicki, 23andMe has been in dialogue with the FDA since 2008.[51] In 2010 the FDA notified several genetic testing companies, including 23andMe, that their genetic tests are considered medical devices and federal approval is required to market them.[32][55] 23andMe first submitted applications for FDA clearance in July and September 2012.[3] On November 22, 2013, after not hearing from 23andMe for six months, the FDA ordered 23andMe to stop marketing its Saliva Collection Kit and Personal Genome Service (PGS), as 23andMe had not demonstrated that they have "analytically or clinically validated the PGS for its intended uses" and the "FDA is concerned about the public health consequences of inaccurate results from the PGS device".[3][56][57] As of December 2, 2013, 23andMe has stopped all advertisements for its PGS test but is still selling the product.[58][59] As of December 5, 2013, 23andMe is selling only raw genetic data and ancestry-related results.[4][26][27]

According to science writer Razib Khan, this development ultimately will not matter as raw genetic results can be obtained cheaply from international genome sequencing firms and open source tools to analyse such data using published scientific research are freely available.[60] Ronald Bailey writes in Reason Magazine: "The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous."[61] Technology writer Timothy B. Lee argues in the Washington Post against the FDA preventing consumer access to personal health information provided by 23andMe, stating that any risky medical decisions patients made based on 23andMe's services would require the involvement of licensed medical professionals.[62] TechFreedom promoted a petition asking the FDA not to ban 23andMe's home genome testing kits.[61] Science and medicine writer Matthew Herper was more critical of 23andMe, writing in Forbes magazine: "The FDA probably felt it had little choice. This is not the story of a big regulator choosing to squash a small company, but of a company that decided that it didn't have to follow the rules."[63]

23andMe publicly responded to media reports on November 25, 2013, stating, "We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."[60][64][65] Anne Wojcicki subsequently posted an update on the 23andMe website, stating: "This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety."[51]

On December 5, 2013, 23andMe announced that it has suspended health-related genetic tests for customers who purchased the test from November 22, 2013 in order to comply with the FDA warning letter while undergoing regulatory review.[4][26][27]

In May 2014 it was reported that 23andMe was exploring alternative locations abroad including Canada, Australia and the United Kingdom in which to offer its full genetic testing service.[66] 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014,[6][7][8] and in the United Kingdom since December 2014.[9]

On February 19, 2015, the FDA announced that it had approved a 23andMe test for Bloom syndrome.[67]

On October 21, 2015, 23andMe announced that it would be including a revised health component in the United States with FDA approval.[5]

On October 26, 2016, CEO Anne Wojcicki said, "There was part of us that didn’t understand how the regulatory environment works" in regards to the distributed laboratory regulatory functions of FDA and CMS.[68]

On November 27, 2013, 23andMe customer Lisa Casey filed a class action lawsuit against 23andMe in the Southern California federal district court for misleading advertising of its PGS test "when there is no analytical or clinical validation for the PGS for its intended uses". Casey is suing for at least $5 million in damages, representing the aggregate of the $99 PGS test purchase price paid by thousands of customers the plaintiff believes to be in the class.[69][70][71]